BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL LINE W/PILLOW NO LEPARIN LINE

    MDR report key: 32114 · Received January 25, 1996

    Report

    Report Number
    32114
    Event Type
    Injury
    Date Received
    January 25, 1996
    Date of Event
    September 8, 1995
    Report Date
    September 14, 1995
    Manufacturer
    MEDICAL PRODUCTS DIV. NATIONAL MEDICAL CARE, INC.
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT STATED SHE "FELT BAD" PRE-TREATMENT. O2 STARTED AT 2L. HER ORDERED BLOODFLOW WAS 400ML BUT HAD TO BE DECREASED TO 300 DUE TO A POOR FLOW. TOWARD THE END OF HER 3 1/2 HR TREATMENT, SHE COMPLAINED OF HAVING "GAS" AND BURPED. HER BP DROPPED TO 114/60 BUT WENT BACK UP TO 130/60. HER TREATMENT FINISHED AND SHE LEFT THE UNIT TO GO BACK TO HER ROOM. LATER THAT DAY THE PHYSICIAN CALLED THE UNIT AND STATED THE PT'S LDH WAS 2000 AND THE PT'S BLOOD WAS HEMOLYZED. THE MGMT TEAM WAS THEN TOLD BY THE PT CARE TECH THAT A KINK WAS SEEN IN THE ARTERIAL LINE IN THE BLOOD PUMP HOUSING WHEN THE LINES AND DIALYZER WERE TAKEN OFF THE DIALYSIS MACHINE. THE LINES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL LINE W/PILLOW NO LEPARIN LINE ARTERIAL BLOODLINE FJK MEDICAL PRODUCTS DIV. NATIONAL MEDICAL CARE, INC. 9608 R48028

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization